Lexicon to Present Data on Effect of Kidney Function on the Long-term Efficacy and Safety of Sotagliflozin in Patients with Type 1 Diabetes at 19th International Conference on Advanced Technologies & Treatments for Diabetes
THE WOODLANDS, Texas, March 11, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that results of a post hoc analysis of clinical data evaluating the impact of kidney function on the long-term efficacy and safety of sotagliflozin on people with type 1 diabetes will be delivered as a short oral presentation tomorrow, March 12, during the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The congress is being held March 11-14, 2026, in Barcelona, Spain.
"Recognizing that a patient's kidney function can impact the efficacy of SGLT inhibitors, we conducted this post hoc analysis of clinical data from two identically-designed trials in patients with type 1 diabetes and were encouraged to find that treatment with sotagliflozin resulted in improvements in multiple efficacy measures after one year in both those with normal kidney function and those with mildly reduced kidney function," said Craig Granowitz, M.D., Ph.D., Lexicon's senior vice president and chief medical officer. "Not only was sotagliflozin shown to improve cardiometabolic parameters in this patient population, but it also reduced clinically important hypoglycemia events, which are a leading cause of acute mortality and morbidity and can be life-threatening."
Using pooled data from two 52-week, placebo-controlled trials of 200 mg or 400 mg doses of sotagliflozin added to optimized insulin, investigators compared the efficacy (as measured by HbA1c, body weight and systolic blood pressure) and safety (as measured by hypoglycemia and diabetic ketoacidosis) of 200 mg or 400 mg doses of sotagliflozin as compared to the placebo treatment arms in such studies, subgrouped by estimated glomerular filtration rates (eGFR, a measure of kidney function) of 45 to <60 (chronic kidney disease [CKD] Class 3A), 60 to <90 (CKD Class 2), and ≥90 mL/min/1.73m2 (CKD Class 1).
Results showed that both doses of sotagliflozin significantly decreased HbA1c, body weight, systolic blood pressure and total insulin use compared to placebo after 52 weeks in patients with CKD Class 1 and 2. These positive effects with sotagliflozin were not as pronounced in patients with CKD Class 3A. Additionally, sotagliflozin reduced events of blood glucose ≤55 mg/dL (3 mmol/L) regardless of patients' kidney function. Results did not show a trend toward increased incidence of diabetic ketoacidosis based on patients' kidney function.
Lexicon remains on track to resubmit the New Drug Application (NDA) for ZYNQUISTA® (sotagliflozin) glycemic control in patients with type 1 diabetes in 2026 based upon U.S. Food and Drug Administration (FDA) feedback and additional clinical data received to date from the STENO1 study (Clinicaltrials.gov: NCT06082063). STENO1 is a third-party funded, investigator-initiated study of sotagliflozin and other agents being conducted by the Steno Diabetes Center in Denmark.
About Sotagliflozin
Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM).
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements, including, without limitation, statements about the completion and timing of the offering, the use of proceeds from the offering and the grant of the option to the underwriters and the private placement purchaser to purchase additional shares, are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's Annual Report on Form 10-K for the year ended December 31, 2025 and other subsequent disclosure documents filed with the SEC. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
[email protected]
